What’s on the horizon: mandatory FDA PDUFA V Per PDUFA V Commitment, FDA shall issue final guidance on the standards and format of electronic submission of drug marketing application by end of 2014. All new original NDA and BLA submissions, supplements and amendments are required to follow the final guidance by end of 2016. All […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2014-03-08 16:54:102014-03-08 16:54:10Prepare now for adoption of ADaM standard
Prepare now for adoption of ADaM standard
in Getting FDA ApprovalWhat’s on the horizon: mandatory FDA PDUFA V Per PDUFA V Commitment, FDA shall issue final guidance on the standards and format of electronic submission of drug marketing application by end of 2014. All new original NDA and BLA submissions, supplements and amendments are required to follow the final guidance by end of 2016. All […]